4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications.

Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or through the US FDA master file program.

1. Scope

1.1 This guide is intended to educate potential users of silicone elastomers, gels, and foams relative to their formulation and use. It does not provide information relative to silicone powders, fluids, and other silicones. The information provided is offered to guide users in the selection of appropriate materials, after consideration of the chemical, physical, and toxicological properties of individual ingredients or by-products. This guide offers general information about silicone materials typically used for medical applications. Detail on the crosslinking and fabrication of silicone materials is found in Part II of this guide.

1.2 Fabrication and properties of elastomers is covered in the companion document, F604, Part II. This monograph addresses only components of uncured elastomers, gels, and foams.

1.3 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use.

1.4 Biological and physical properties tend to be more reproducible when materials are manufactured in accordance with accepted quality standards such as ANSI ISO 9001 and current FDA Quality System Regulations/Good Manufacturing Practice Regulations.

1.5 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Users are also advised to refer to Material Safety Data Sheets provided with uncured silicone components.

Most popular related searches

Related news

Board Actions
Finance and Audit
The board approved all proposed ASTM budgets as well as the appointment of Taco van der Maten to serve as chairman of the 2016 Finance and Audit Committee. Van der Maten is marketing manager at PANalytical in Almelo, the Netherlands. He is chairman of Committee F40 on Declarable Substances in Materials and a member of Committees D02 on Petroleum Products, Liquid Fuels and Lubricants and D20 on Plastics. Van der Maten has served on our board since 2013.
Mission Statement
The...

Laboratories will soon be able to use a new ASTM International standard to test and better understand biodegradability of plastics in marine environments. The new standard (soon to be published as D7991, Test Method for Determining Aerobic Biodegradation of Plastics Buried in Sandy Marine Sediment Under Controlled Laboratory Conditions) provides ways to simulate how plastics degrade in seawater-soaked sand.
According to ASTM member Francesco Degli Innocenti, the recent discovery of major contamination in the...

In the world of construction materials, ASTM International standards are as much a part of doing business as chemical admixtures are a part of concrete. It takes a combination of sound scientific protocol and industry-leading chemical technologies to develop and implement chemical admixtures and cement additives for the construction industry.
Whether concrete or hydraulic cement, ASTM standard specifications and test methods are always at the forefront of the process, from the evaluation of raw materials to the...

ASTM has selected Derek Burling, an electrical engineering student at the University of Wisconsin – Madison, as the student we are sponsoring for the 2015 Washington Internships for Students of Engineering program.
Ranked as one of the best internship opportunities in the United States by the Princeton Review, WISE is a paid 10-week summer program held in Washington, D.C. The interns are outstanding third- or fourth-year engineering students selected in a nationwide competition. During their stay, interns...

ASTM International is partnering with the International Code Council to support the use of codes and standards in sustainable construction in the Middle East. The partnership is a component of the Standards and Codes for Sustainable Construction project and is funded in part through the Market Development Cooperator Program at the U.S. Department of Commerce’s International Trade Administration. The goal is to enhance the Gulf region’s efforts in areas such as energy efficiency, water conservation,...

Customer comments

No comments were found for ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials. Be the first to comment!